The validation of a new catheter for intermittent Self-Catheterization in female patients; proof of principles

The validation of a new catheter for intermittent Self-Catheterization in female patients; proof of principles - FemFlow catheter

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42152

Enrollment

Registered

2015-06-09

Start date

2015-11-20

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acontractile or underactive bladder dysfunction: inability to empty the bladder

Interventions

incomplete bladder emtying

intermittent self-catheterization

lower urinary tract dysfunction

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Female patients with normal anatomy of urethra en bladder.

Exclusion criteria

Exclusion criteria: Multiple operations in bladder and/or urethra. Deformities of the urethra

Design outcomes

Primary

Measure	Time frame
Ease of insertion (Qualitative) Indication of pull force required to drain the bladder (Newtons) Time needed to empty the bladder (Seconds) Rebound of the catheter back into the bladder and the assessment of any urine leakage (Qualitative) Indication of pull force required for retraction of FemFlow from the bladder (Newtons)	—

Secondary

Measure	Time frame
Mucosa damage (Qualitative)	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)